Effect of Foot Reflexology on Preeclampsia

NCT ID: NCT05888896

Last Updated: 2023-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-09

Study Completion Date

2023-09-20

Brief Summary

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the aim of this study to investigate the effect of foot reflexology on mild preeclampsia during pregnancy

Detailed Description

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Preeclampsia is defined as arterial hypertension identified for the first time after the 20th week associated with proteinuria. It affects 5% to 7% of all pregnant women. It is more common in primigravida women, women with previous early onset preeclampsia, in age greater than 40 years, previous history of preeclampsia, pre-pregnancy obesity, women who become pregnant with donor eggs, embryo donation and donor insemination. It is responsible for over 70 000 maternal deaths and 500 000 fetal deaths worldwide every year. There are many risk factors for it as: Hypertension, diabetes mellitus, proteinuria, obesity, family history, null parity, multiple pregnancies, use of contraception, older women conception (\> 40) and thrombotic vascular disease,edema, renal failure, liver failure and hellp syndrome.Complementary therapies such as massage and foot reflexology are used with patients of preeclampsia, it is to normalize the body's function, break down tension, alleviate stress, improve nerve function and blood supply throughout the body. this trial has two groups; one will receive anti-hypertensive drugs and the second will receive anti-hypertensive drugs+foot reflexology sessions for 8 weeks (30 min, 2 session/ week).

Conditions

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Mild Pre-eclampsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

anti-hypertensive drugs and foot reflexology
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
double( Participants, outcomes Assessor)

Study Groups

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anti-hypertensive drugs

Methyldopa tablets 250 mg will be used oral to reduce hypertension

Group Type EXPERIMENTAL

methyldopa tablets 250mg

Intervention Type OTHER

patients will be taken methyldopa tablets 250mg in the morning orally with a lot of water after breakfast daily and this medication continues for 8 weeks

anti-hypertensive drugs+foot reflexology

Methyldopa tablets 250 mg and foot reflexology sessions for 8 weeks ( 30 min 2 times per week) will be used to reduce hypertension

Group Type EXPERIMENTAL

methyldopa tablets 250mg + foot reflexology

Intervention Type OTHER

patients will receive methyldopa tablets 250mg in oral way once daily per 8 weeks and patients will receive foot reflexology two sessions per week, every session will last for 30 minutes and sessions will last for 8 weeks.

Interventions

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methyldopa tablets 250mg

patients will be taken methyldopa tablets 250mg in the morning orally with a lot of water after breakfast daily and this medication continues for 8 weeks

Intervention Type OTHER

methyldopa tablets 250mg + foot reflexology

patients will receive methyldopa tablets 250mg in oral way once daily per 8 weeks and patients will receive foot reflexology two sessions per week, every session will last for 30 minutes and sessions will last for 8 weeks.

Intervention Type OTHER

Other Intervention Names

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anti-hypertensive drugs anti-hypertensive drugs+ foot massage

Eligibility Criteria

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Inclusion Criteria

* Their ages were ranged between 20-36 years old.
* Their body mass index was not exceeding 35 kg/m2.
* All women were diagnosed as mild preeclampsia.
* All women were primipara and multipara.

Exclusion Criteria

* Any fractures in foot.
* Foot ulcer \& infection.
* Open skin wound in foot.
* History of stroke.
* Women less than 20 years and more than 36 years.
* BMI more than 35 Kg\\m2.
* Severe preeclampsia.
Minimum Eligible Age

20 Years

Maximum Eligible Age

36 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Abeer Ali Ahmed Mansour

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Abeer Ali Ahmed Mansour

Asyut, Assuit, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Abeer Ali, lecturer

Role: CONTACT

01142602929

Facility Contacts

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Abeer Ali, Lecturer

Role: primary

01142602929

Other Identifiers

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p.t.REC/012/003568

Identifier Type: -

Identifier Source: org_study_id

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